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RegisterBorderline BE study Failure [Study Assessment]
Agree with Bloom,
Better to reformulate since your T/R ratios are way too low.
Question:
Why did you run a full replicate study? Based on your data the drug doesn't look like a HVD (unless your pilot data suggested)
John
Better to reformulate since your T/R ratios are way too low.
Question:
❝ For Product X (IR tablets), full replicated BE study was performed on 56 volunteers under fasting state (EU submission).
Why did you run a full replicate study? Based on your data the drug doesn't look like a HVD (unless your pilot data suggested)
John
Complete thread:
- Borderline BE study Failure Samaya B 2014-10-14 09:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Borderline BE study Failure luvblooms 2014-10-14 11:03
- Borderline BE study Failurejag009 2014-10-14 16:59
- Interim analysis Ohlbe 2014-10-14 23:53
- Borderline BE study Failure Helmut 2014-10-15 15:29
Ing. Helmut Schütz